Analysis of an interaction threshold in a mixture of drugs and/or chemicals

Statistics in Medicine

Volumn 24, Issue 16, 2005, Pages 2493-2507

  Hamm, Adam K ^a   Carter Jr , W Hans ^b   Gennings, Chris ^b  

^a RHO INC   (United States)

^b VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

Author keywords

Chemical mixtures; Dose dependent interaction; Drug combinations; Segmented regions; Synergism; Threshold model

Indexed keywords

ALCOHOL; CHLORAL HYDRATE;

ARTICLE; CHEMICAL INTERACTION; CONTROLLED STUDY; DOSE RESPONSE; DRUG ALCOHOL INTERACTION; DRUG EXPOSURE; ENVIRONMENTAL EXPOSURE; HYPOTHESIS; RISK ASSESSMENT; STATISTICAL ANALYSIS; STATISTICAL MODEL;

ANIMALS; CHLORAL HYDRATE; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG COMBINATIONS; DRUG INTERACTIONS; ETHANOL; HUMANS; LINEAR MODELS; MICE; MODELS, BIOLOGICAL;

EID: 23244457753     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.2110     Document Type: Article

References (34)

1. Konemann WH, Pieters MN. Confusion of concepts in mixture toxicology. Food and Chemical Toxicology 1996; 34(11,12):1025-1031.
2. Gennings C, Carter Jr WH, Campain J, Bae D, Yang R. Statistical analysis of interactive cytotoxicity in human epidermal keratinocytes following exposure to a mixture of four metals. Journal of Agricultural, Biological, and Environmental Statistics 2002; 17:58-73.
3. U.S. Environmental Protection Agency. Guidelines for the health risk assessment of chemical mixtures. EPA/630/R-98/002. National Center for Environmental Assessment, Office of Research and Development, Washington, DC, 51 FR 34014, 1986. Accessed most recently June 19, 2003 from http://www.epa.gov/ncea/raf/pdfs/chem_mix/chemmix_1986.pdf
4. U.S. Environmental Protection Agency. Supplementary guidance for conducting health risk assessment of chemical mixtures. USEPA EPA/630/R-00/002. National Center for Environmental Assessment, Office of Research and Development, Washington, DC, 51 FR 34014, 2000. Accessed most recently June 19, 2003 from http://www.epa.gov/NCEA/raf/chem_mix.htm
5. U.S. Environmental Protection Agency. Guidance on cumulative risk assessment of pesticide chemicals that have a common mechanism of toxicity. USEPA EPA/630/R-00/002. Office of Pesticide Programs, Washington, DC, 51 FR 34014, 2002. Accessed most recently June 19, 2003 from http://www.epa.gov/pesticides/trac/science/cumulative_guidance.pdf
6. Carpy SA, Kobel W, Doe J. Health risk of low-dose pesticides mixtures: a review of the 1985-1998 literature on combination toxicology and health risk assessment. Journal of Toxicology and Environmental Health. Part B, Critical Reviews 2000; 3:1-25.
7. Gessner PK, Cabana BE. A study of the interaction of the hypnotic effects and of the toxic effects of chloral hydrate and ethanol. The Journal of Pharmacology and Experimental Therapeutics 1970; 174:247-259.
8. Carter Jr WH, Gennings C, Staniswalis JG, Campbell ED, White KL. A statistical approach to the construction and analysis of isobolograms. Journal of the American College of Toxicology 1988; 7:963-973.
9. Kelly C, Rice J. Monotone smoothing with application to dose-response curves and the assessment of synergism. Biometrics 1990; 46:1071-1085.
10. Gennings C. An efficient experimental design for detecting departure from additivity in mixtures of many chemicals. Toxicology 1995; 105:185-197.
11. Dawson KS, Carter Jr WH, Gennings C. A statistical test for detecting and characterizing departures from additivity in drug/chemical combinations. Journal of Agricultural, Biological, and Environmental Statistics 2000; 5:342-359.
12. Berenbaum MC. Criteria for analyzing interactions between biologically active agents. Advances in Cancer Research 1981; 35:269-335.
13. Loewe S. The problem of synergism and antagonism of combined drugs. Arzneimittle Forshung 1953; 3: 285-290.
14. Loewe S, Muischnek H. Uber Kombinations-Wirkungen. 1. Mitteilung: Hilfsmittle der Fragestel-lung. Archives of Experimental Pathology and Pharmacology 1926; 114:313-326.
15. McCullagh P, Nelder JA. Generalized Linear Models (2nd edn). Chapman & Hall: New York, 1989; 1-511.
16. Gessner PK, Cabana BE. Chloral alcoholate: reevaluation of its role in the interaction between the hypnotic effects of chloral hydrate and ethanol. The Journal of Pharmacology and Experimental Therapeutics 1967; 156:602-605.
17. Gallant AR, Fuller WA. Fitting segmented polynomial regression models whose join points have to be estimated. Journal of the American Statistical Association 1973; 68:144-147.
18. Wedderburn RWM. Quasi-likelihood functions, generalized linear models, and the Gauss-Newton method. Biometrika 1974; 61:439-447.
19. McCullagh P. Quasi-likelihood functions. The Annals of Statistics 1983; 11:59-67.
20. Nelder JA, Mead R. A simplex method for function minimization. The Computer Journal 1965; 7:308-313.
21. Schwartz PF, Gennings C, Chinchilli VM. Threshold models for combination data from reproductive and developmental experiments. The Journal of the American Statistical Association 1995; 90:862-870.
22. Hinkley DV. Inference about the intersection in two-phase regression. Biometrika 1969; 56:495-504.
23. Seber GAF, Wild CJ. Nonlinear Regression. Wiley: New York, 1989; 1-768.
24. Feder PI. The log likelihood ratio in segmented regression. The Annals of Statistics 1975; 3:84-97.
25. Yang RSH, El-Masri HA, Thomas RS, Constan AA, Tessari JD. The application of physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) modelling for exploring risk assessment approaches of chemical mixtures. Toxicology Letters 1995; 79:193-200.
26. El-Masri HA, Constan AA, Ramsdell HS, Yang RSH. Physiologically based pharmacokinetic modeling of an interaction threshold between trichloroethylene and 1,1-dichloroethylene in Fischer 344 rats. Toxicology and Applied Pharmacology 1996; 141:124-132.
27. El-Masri HA, Tessari JD, Yang RSH. Exploration of an interaction threshold for the joint toxicity of trichloroethylene and 1,1-deichloroethylene: utilization of a PBPK model. Archives of Toxicology 1996; 70: 527-539.
28. El-Masri MA, Yushak ML, Mumtaz MM. Development of a response surface for the toxicological interaction between chlorpyrifos and parathion using physiologically based pharmacokinetic modeling. Toxicologist 2002; 66(1-S):36.
29. Dobrev ID, Andersen ME, Yang RSH. Assessing interaction thresholds for trichloroethylene in combination with tetrachloroethylene and 1,1,1-trichloroethane using gas uptake studies and PBPK modeling. Archives of Toxicology 2001; 75:134-144.
30. Lutz WK. Susceptibility differences in chemical carcinogenesis linearize the dose-response relationship: threshold doses can be defined only for individuals. Mutation Research 2001; 482:71-76.
31. Kroes R, Galli C, Munro I, Schilter B, Tran L, Walker R, Wurtzen G. Threshold of toxicological concern for chemical substances present in the diet: a practical tool for assessing the need for toxicity testing. Food and Chemical Toxicology 2000; 38:255-312.
32. Sofuni T, Hayashi M, Nohmi T, Matsuoka A, Yamada M, Kamata E. Semi-quantitative evaluation of genotoxic activity of chemical substances and evidence for a biological threshold of genotoxic activity. Mutation Research 2000; 464:97-104.
33. Gennings C, Schwartz P, Carter Jr WH, Simmons JE. Detection of departures from additivity in mixtures of many chemicals with a threshold model. Journal of Agricultural, Biological, and Environmental Statistics 1997; 2:198-211.
34. Gennings C, Schwartz P, Carter Jr WH, Simmons JE. Detection of departures from additivity in mixtures of many chemicals with a threshold model. Journal of Agricultural, Biological, and Environmental Statistics 2000; 5:257-259 (Erratum).